Cleared Traditional

K854112 - FLEXIBLE GRASPING FORCEPS

K854112 is an FDA 510(k) clearance for FLEXIBLE GRASPING FORCEPS, manufactured by Hood Laboratories. The device is a Class 2 Ear, Nose, Throat device with product code EWL cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K854112 · Hood Laboratories · Ear, Nose, Throat device
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Mar 1986
Decision
155d
Days
Class 2
Risk

K854112 is an FDA 510(k) clearance for the FLEXIBLE GRASPING FORCEPS. Classified as Prosthesis, Laryngeal (taub) (product code EWL), Class II - Special Controls.

Submitted by Hood Laboratories (Pembroke, US). The FDA issued a Cleared decision on March 12, 1986 after a review of 155 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3730 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Hood Laboratories devices

FDA 510(k) Submission Details - K854112

510(k) Number K854112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1985
Decision Date March 12, 1986
Days to Decision 155 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 90d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EWL Device Classification - Class 2, Special Controls

Product Code EWL Prosthesis, Laryngeal (taub)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3730
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - EWL Prosthesis, Laryngeal (taub)

All 18
Devices cleared under the same product code (EWL) and FDA review panel - the closest regulatory comparables to K854112.
ESKA-HERRMANN TRACHEOSTOMY VALVE
K871885 · C.R. Bard, Inc. · Jun 1987
BIVONA ECONOMY DUCKBILL VOICE PROSTHESIS
K861088 · Bivona Medical Technologies · Apr 1986
DACOMED CORP. ESKA-HERRMAN VOICE PROSTHESIS
K854118 · Dacomed Corp. · Mar 1986
THE GRONINGEN VOICE PROSTHESIS
K853940 · Hood Laboratories · Dec 1985
BLOM-SINGER LOW PRESSURE VOICE PROSTHES
K842896 · American V. Mueller · Aug 1984
DUCKBILL VOICE PROSTHESIS & TRACHEO
K832967 · American V. Mueller · Dec 1983